Trial · NCT01294553
An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of AVANDAMET Between June 2004 and January 2010
NCT01294553, Completed, GlaxoSmithKline; results first posted 2011-03-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of AVANDAMET Between June 2004 and January 2010. Trials, record NCT01294553. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01294553
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of AVANDAMET Between June 2004 and January 2010
- NCT number
- NCT01294553
- Status
- Completed
- Enrollment
- 717 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Administration of rosiglitazone/metformin
- First posted
- 2011-02-11
- Last updated
- 2017-07-07
- Results first posted
- 2011-03-15
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With an Adverse Event | 41.4 weeks | An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, please see the table entitled "Other (non-serious) adverse events" in the Adverse Event section of the results record. |
| Secondary | Number of Participants With a Serious Adverse Event | 41.4 weeks | A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, please see the table entitled "Serious Adverse Events" in the Adverse Event section of the results record. |
| Secondary | Number of Participants With the Indicated Unexpected Adverse Events | 41.4 weeks | Unexpected adverse events are defined as those that were not described in the locally approved label by the Korean Food and Drug Administration (KFDA) at the time of surveillance completion. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With an Adverse Event | 41.4 weeks | Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had undergone all safety assessments | participants | NUMBER |
| SECONDARY | Number of Participants With a Serious Adverse Event | 41.4 weeks | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Unexpected Adverse Events | 41.4 weeks | ITT Population | participants | NUMBER |
Source ClinicalTrials.gov
Results by group31
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With an Adverse Event | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | 110 | participants | ||
| Number of Participants With a Serious Adverse Event | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | 2 | participants | ||
| Number of Participants With the Indicated Unexpected Adverse Events | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Gastritis | 42 | participants | |
| Number of Participants With the Indicated Unexpected Adverse Events | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Dysaesthesia | 5 | participants | |
| Number of Participants With the Indicated Unexpected Adverse Events | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Impotence | 3 | participants | |
| Number of Participants With the Indicated Unexpected Adverse Events | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Paralysis | 2 | participants | |
| Number of Participants With the Indicated Unexpected Adverse Events | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Insomnia | 2 | participants | |
| Number of Participants With the Indicated Unexpected Adverse Events | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Depression | 2 | participants | |
| Number of Participants With the Indicated Unexpected Adverse Events | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Dermatitis | 2 | participants | |
| Number of Participants With the Indicated Unexpected Adverse Events | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Peptic ulcer | 1 | participants |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | 982 | |
| Overall Study | COMPLETED | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | 713 | |
| Overall Study | NOT COMPLETED | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | 269 |
Source ClinicalTrials.gov
Adverse events15
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Immune system disorders | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | 17 | 713 | |
| other | Oedema | Metabolism and nutrition disorders | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | 16 | 713 | |
| other | Gastritis | Gastrointestinal disorders | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | 9 | 713 | |
| other | Weight increase | General disorders | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | 8 | 713 | |
| other | Dyspepsia | Gastrointestinal disorders | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | 6 | 713 | |
| other | Headache | General disorders | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | 6 | 713 | |
| other | Dysaesthesia | Nervous system disorders | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | 5 | 713 | |
| other | Chest pain | General disorders | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | 4 | 713 | |
| other | Constipation | Gastrointestinal disorders | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | 3 | 713 | |
| other | Fatigue | General disorders | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | 3 | 713 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | ||
| Total, other adverse events | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | 77 | 713 |
| Total, serious adverse events | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | 2 | 713 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01294553
GET https://conductscience.org/api/trials/v1/NCT01294553/results?page=2